FDA steps up criminal enforcement efforts

In the 18 months or so since Margaret Hamburg took the reins at the FDA, we've heard promises of increased enforcement. We've seen some action, too, including a flurry of warning letters. But if regulatory experts are right--and indications from FDA officials prove out--some drug executives are going to need criminal defense lawyers.

The agency is resurrecting the "Park Doctrine," CNN Money reports. That's an old law that allows drug executives to be prosecuted for violations of the Food, Drug and Cosmetic Act, even if they're not directly involved in manufacturing violations--even, in fact, if they're unaware of the problems. As long as they're in a position with the authority to prevent or fix the violations, they're on the hook.

One legal expert says FDA officials now think "working it out with the company and the company doing a voluntary recall is not enough." Another says the agency is trying to send "a clearer message" to companies. "The FDA is developing a tougher compliance attitude," David Rosen, who was formerly with the agency and now works with the law firm Foley & Lardner, tells CNN Money, "because companies are ignoring warnings from the FDA."

The only criminal pharma investigation we know about right now is FDA's probe into Johnson & Johnson's recent recalls. No word on whether the agency might go after individual J&J executives--or indeed try to prosecute the company at all. But the agency promises that criminal prosecutions will come to some company or other. As FDA's Eric Blumberg said a few months ago, "[S]ome corporate executive is going to be the first in a long line."

- get the CNN Money story

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